Operating gown design must consider the protection of the surgeon from fluid penetration by providing an impervious barrier for the torso and forearm. The gown must be easy and quick to put on for both the wearer and gown assistant. It must be more convenient, cheaper and ecologically sound than the non-disposable cloth gowns. The highest reasonable standard of sterility of the operating field must be achieved to avoid surgical patient contamination and post operative wound infections.
Current disposable gown manufacturers have all adopted the same overall design which is similar to that of the traditional cloth gown. The only apparent innovations are in the manufacturing techniques adopted and material types used.
FIGS. 1a to c illustrate the front, back and top views respectively of the current gown design which is used extensively. It consists of neck ties 1 (hook and loop type fasteners are sometimes used here instead of ties), mid-back ties 2, sterile ties 3 and 4, and a sterile paper tie link 5, 6 and 7 are the non-sterile and sterile flaps respectively. The sterile flap 7 is folded back and held there by the connection of the sterile tie 3, paper link 5 and left side sterile tie 4, in the front of the gown. FIGS. 2a and b illustrate the applied gown from the front and the back respectively. The closure of the unfolded sterile flap 7 is shown in FIG. 2b. The sterile flap 7 covers the non-sterile flap 6 and non-sterile tie connections 2. The neck tie closure 1 is exposed. FIG. 2a also shows the sterile tie connection between ties 3 and 4.
The sterile zone 8 can be defined as a three-dimensional arc wedge as shown in FIGS. 3a and b. The base and the top of the wedge extends from the waist to the nipple line with the tip at the centre of the surgeon. The sides of the wedge radiate at an angle 13 of approximately 40.degree. to the back plane of the surgeon.
Prior to putting on the gown, the surgeon is first scrubbed and then proceeds to unfold the gown. This is done by holding the gown at the neck and letting it unfold towards the ground without actually reaching it. The surgeon then proceeds to pass both arms through the respective arms of the gown alone. The gloves are put on next by the surgeon. The gown assistant steps behind the surgeon while they are applying the gloves or right afterwards and begins to apply the ties at the rear of the gown. The assistant first applies the neck tie 1 and then proceeds to tie the mid-back tie 2 (see FIG. 1). Both are non-sterile ties. Once this is complete the gown assistant 10 then moves to the front right side of the surgeon 9 as shown in FIGS. 4a and b. The surgeon 9 then undoes the connection of the sterile tie 4 from the paper tie link 5 while maintaining its connection with the sterile tie 3. The tie link 5 is held in the right hand of the surgeon 9 who then reaches it out to the assistant 10 to hold. At this point, either the surgeon 9 turns counter clockwise on the spot 11 with arms raised high while the assistant 10 stands still as in FIG. 4a, or the surgeon 9 stands still with the arms raised high while the assistant 10 walks clockwise 12 around the back of the surgeon. In either case, the assistant will end up on the front left side of the surgeon while still holding the paper tie link 5. The surgeon then pulls the sterile tie 3 off the link 5 and proceeds to tie it to the sterile tie 4 and thus makes the final connection as shown in FIG. 2a. Gown assistants are usually unscrubbed (i.e. unclean). Sometimes the final tie is assisted by a scrubbed (i.e. clean) assistant.
The current gown design presents a number of problems requiring attention. The surgical gowns are commonly put on in the operating theatre or at least the final sterile tie is completed in the theatre. Discipline in the operating room is important to minimise accidental contamination of the gown and by the gown. One way of decreasing contamination is by reducing air currents and the amount of movement in the operating theatre, thereby decreasing the opportunity for contamination.
The sterile tie 3 may break during the final twirl if the paper link 5 is pulled too tightly or is yanked by the assistant 10 (see FIG. 4). It is more common for the sterile tie 3 to become disconnected with the paper link 5. In both instances, the damaged gown is discarded and a new gown must be put on.
During the application of the sterile flap 7 using the sterile tie 3, air currents are generated during the turning process illustrated in FIG. 4. This is true in either case. The case where the assistant turns around the surgeon while holding the paper link 5 is more severe since the sterile flap 7 acts as a sail, causing air to move, and the general range of movement is much larger.
When the surgeon 9 turns on the spot for the final sterile tie 3 application as shown in FIG. 4a, the unclean back of the surgeon may come into contact with sterile draping in the theatre.
Confusion often occurs as to which direction one must turn during the final step of gown application.
Throughout the application of the current gown it becomes necessary for the surgeon's hands to approach the extremes of the sterile zone a number of times (see FIG. 3). When commencing the sterile flap application, the sterile paper tie link 5 (see FIG. 4) is handed to the gown assistant. The surgeon's right hand is at the right extreme of the sterile zone. When the turn is complete, the surgeon's left hand is at the left extreme of the sterile zone. When the turn is complete, the surgeon's left hand is at the left extreme of the zone as it receives and disconnects the sterile tie 3 from the link 5 and proceeds to tie it to 4 with both hands. Both arms are raised during the turn thus approaching the upper ceiling of the sterile zone. The right hand of the surgeon comes within about 10 cm of the unclean hand of the gown assistant as the assistant receives the sterile tie link 5. The sterile zone of the surgeon is invaded by the body of the assistant during the application of the sterile flap 7. When the final tie 3 is assisted by a sterile assistant, then the unclean back of the surgeon invades the sterile zone of the sterile assistant during the turn.
When the gown is fully worn, the sterile straps (i.e. 3 and 4 in FIG. 2a) on the left side remain exposed. During the operation, these ties may get entangled with the surroundings (i.e. with stands, medical devices, etc.) and cause tearing. A new gown must be used in order to maintain sterility.